Summary:
SentryDx is a cancer diagnostic company. Our test will save lives by accurately diagnosing residual cancer earlier than the current standard of care using a blood draw, called a liquid biopsy.
SentryDx has developed a patent pending technology for accurately diagnosing cancer recurrence using Liquid Biopsy and Passive Enrichment, a process we call Bicycle PCR. Two-cycles Allows for internal process control. Our goal is to get regulatory approval for our highly accurate method of detecting low-frequency cancer mutations from a blood draw.
Q & A:
How is SentryDx different?
- All major competitors first "look for" cancer DNA. SentryDx first "looks for" normal DNA.
How does SentryDx "look for" normal DNA?
- SentryDx uses a blocker which targets normal DNA. Cancer DNA is rare, like finding a needle in a haystack. By blocking normal DNA first, SentryDx can turn a needle in a haystack into a mountain of needles.
What is the advantage of a blocker?
- Near perfect accuracy by eliminating problems associated with DNA base pair mismatch and variant dropout.
- A blocker also reduces the amount of sequencing required because cancer DNA is no longer rare. Competitors require >100,000 reads, where SentryDx only needs 100 reads greatly lowing the cost of for sequencing.
What is the accuracy of SentryDx?
- SentryDx can deliver high sensitivity and high specificity at the same time, providing near perfect results for the absence/presence determination of cancer DNA.
What is the sensitivity of SentryDx?
- SentryDx can accurately detect a single copy of cancer DNA. SentryDx can reliably detect a sample with 0.01% cancer using genomic DNA.
- SentryDx is Best in Class for Specificity with NO false positives and Limit of Detection (LoD).
What is the specificity of SentryDx?
- SentryDx should have a specificity near 100% while maintaining a sensitivity of 0.01%
Are the SentryDx process results quantifiable?
Can the SentryDx process be approved by the FDA?
- Since the SentryDx process is standardized, we believe we have a path to FDA approval.
What instruments are required for the SentryDx process?
- SentryDx uses a standard thermal cycler and Sanger sequencing which will reduce the cost to 1/10th the cost of others.